TOFRANIL

What it is

Tofranil is imipramine hydrochloride supplied as tablets containing either 10 mg or 25 mg of the active ingredient. Imipramine is a tricyclic antidepressant with multiple pharmacological actions, with therapeutic activity believed to be based mainly on its ability to inhibit the neuronal re-uptake of noradrenaline and serotonin.

Approved indications

— Major depression. — Nocturnal enuresis from the age of 5 years onwards, provided the possibility of organic causes has first been excluded.

Dosing overview

Dosage should be determined individually and adapted to the patient's condition, with every effort made to achieve an optimum effect while keeping the dose as low as possible and increasing the dosage cautiously, particularly in elderly patients.

Key safety warnings

The risk of suicide is inherent in depression and may persist until significant remission occurs. Patients may experience worsening of depressive symptoms and emergence of suicidal ideation whether or not taking antidepressants. Patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of treatment or at times of dose changes. Patients and caregivers should be alerted about the need to monitor for any worsening of condition and emergence of suicidal ideation or thoughts of harming themselves, and to seek medical advice immediately if these symptoms present. Caution is required in patients with cardiovascular diseases, cardiac disease, and elderly patients, given tachycardiac and hypotensive effects. Cardiovascular insufficiency, conduction disorders, atrioventricular block, and arrhythmias require cardiovascular monitoring and ECG assessment, especially in elderly patients, as myocardial infarction, congestive cardiac failure, stroke and sudden death have been reported with this drug class. Isolated cases of QTc prolongation and very rare cases of ventricular tachycardia and sudden unexplained death have occurred at supra-therapeutic doses. Concomitant administration of medicines that can provoke prolonged QT syndrome should be avoided. Tricyclic antidepressants may cause paralytic ileus, particularly in elderly and bedridden patients with chronic constipation. Blood count should be monitored during treatment, particularly if the patient develops fever or sore throat, since isolated cases of agranulocytosis have been associated with tricyclic antidepressants, especially during the first few months and prolonged treatment.

Contraindications

— Known hypersensitivity to imipramine or any of the excipients in the tablets. — Cross-sensitivity to tricyclic antidepressants of the dibenzazepine group. — Concomitant use with a MAO-inhibitor, or within 14 days before or after treatment with an irreversible MAO inhibitor, or within 14 days before moclobemide, a reversible MAO inhibitor. — Acute and recovery stages of myocardial infarction. — Subjects under 18 years of age for the treatment of depression or other psychiatric disorders.

PBS listing

Tofranil 10 mg tablets are listed on the PBS as one unrestricted item with an ex-manufacturer price of A$3.97. Tofranil 25 mg tablets are listed as one unrestricted item with an ex-manufacturer price of A$7.11.

Regulatory history

Tofranil 10 mg was first registered on the Australian Register of Therapeutic Goods on 2 August 1991. Tofranil 25 mg was first registered on 16 September 1997.